Combined Deep Brain Stimulation for Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01485276|
Recruitment Status : Withdrawn
First Posted : December 5, 2011
Last Update Posted : March 12, 2018
|First Submitted Date ICMJE||December 2, 2011|
|First Posted Date ICMJE||December 5, 2011|
|Last Update Posted Date||March 12, 2018|
|Start Date ICMJE||November 8, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in the amount of time needed to complete a standardized timed up and go (TUG) study at 6 months post-surgery on stimulation|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01485276 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combined Deep Brain Stimulation for Parkinson's Disease|
|Official Title ICMJE||Pilot Study of Bilateral Pedunculo-Pontine Nucleus (PPN) Deep Brain Stimulation for Patients With Parkinson Disease (PD) Who Have Persistent Gait Disturbance, Despite Bilateral Subthalamic Nucleus (STN) Deep Brain Stimulation|
- Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for Parkinson s disease. It stimulates a part of the brain that helps control symptoms like tremor, stiffness, and slow movements. However, many people continue to have unsteadiness and slowness while walking, trouble swallowing, and speech problems even with STN DBS. Another type of DBS focuses on a part of the brain called the pedunculopontine nucleus (PPN). PPN DBS has improved walking in some people with Parkinson's disease. Researchers want to see if combining the two types of DBS may help control symptoms better than STN DBS alone.
- Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but still have difficulty walking, swallowing, and speaking.
Three (3) subjects with clinically diagnosed PD who have undergone bilateral STN DBS at least one year prior to enrollment, who continue to have gait and balance disturbance.
Pilot study of 3 patients with clinically diagnosed PD who have undergone bilateral STN DBS at least one year prior to enrollment. Baseline evaluation will include neurologic clinical evaluation, postural and gait physiologic and clinical assessment, brain imaging, and video swallow evaluation. The patients will undergo the surgical procedure (bilateral PPN DBS implant) in the Clinical Center (CC). Electrode recordings will be obtained from the implant site within the first week post-operatively from an externalized lead, then the second surgical stage (pulse generator implant) will take place, also in the Clinical Center. The patients will undergo programming to optimal parameters and appropriate follow-up, and the outcome measures will be assessed at 1 week and 1, 3, 6 and 12 months post-surgery. Recruitment will be staggered and at least 4 weeks will be required between different patients beginning the study. Recruitment will be halted if major unexpected side-effects occur causing concern about the welfare of patients.
This study is to serve as the basis for an extended, larger study, which would be properly powered to answer the clinical research questions. The efficacy criterion for translation into a larger study will be 30% improvement in the primary outcome in 2 out of the 3 patients. In addition, we will obtain valuable and for the most part novel data regarding the electrophysiologic properties of the PPN and the complex interactions between basal ganglia (BG) components in the parkinsonian state and the response to DBS. The data obtained in this study will inform the design, selection and treatment paradigms in future larger studies.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Parkinson Disease|
|Intervention ICMJE||Procedure: DBS Surgery|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||July 30, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
i. Greater than 22 years of age
ii. Successful bilateral STN DBS implants for at least 1 year
iii. At least 30% improvement in the motor UPDRS following STN therapy, by history and record review
iv. Improved UPDRS and self assessment questionnaire following STN DBS by at least 20%, by history and record review.
v. Good STN DBS placement assessed with imaging (CT scan, MRI or fused CT-MRI imaging)
vii. Persistent gait disturbance as ascertained by abnormal performance on the time-up-and-go test compared to age-matched controls as well as preoperative evaluation with posturography and quantitative gait assessment (values compared to normal age-matched controls) at least 30% difference from age-matched controls on either measure.
vii. Persistent speech and swallowing problems as measured by a minimum score of I in items 5 and 7 of the UPDRS
viii. Evaluation by an independent movement disorders specialist who will confirm gait disturbance in the presence of STN stimulation.
i. Pregnant or nursing women
ii. Cognitively impaired subjects as determined by pre-operative neuropsychology evaluation, including Mattis Dementia Rating Scale (DRS). Patients scoring below 70 on the Mattis DRS will be excluded.
iii. Depressed subjects as determined by the neuropsychology screen, including Beck Depression Inventory. Patients scoring above 20 on the Beck inventory will be excluded.
iv. Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; heart disease needing intervention; respiratory disease needing intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
v. Patients with metal objects in their body that are not MRI compatible, excluding the previous STN DBS hardware
vi. Patients who have a history of seizures, require repeated magnetic resonance imaging (MRI) scans or have had a cranial neurosurgical procedure since receiving an STN implant.
|Ages||22 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT01485276|
|Other Study ID Numbers ICMJE||120012
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 30, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP